Reps. introduce another compounding bill

Reps. Rosa DeLauro (D-Conn.) and Nita Lowey (D-N.Y.) introduced the Supporting Access to Formulated and Effective (S.A.F.E.) Compounded Drugs Act, which would require healthcare providers to inform patients they are receiving a compounded drug and would require pharmacists to confirm that patients know a drug is compounded prior to dispensing. The bill, which also would require compounded drugs to be labeled as compounded, would instruct compounding pharmacies to register their facility with FDA and would require the agency to establish a database of information on pharmacies. Under the bill, FDA would also have to set minimum production standards and offer training opportunities for state regulators.

Last month, Rep. Edward Markey (D-Mass.) introduced the Verifying Authority and Legality in Drug (VALID) Compounding Act (H.R. 6584), which would give FDA the authority to oversee compounding pharmacy practices. The bill has been referred to the House Energy and Commerce Committee (see BioCentury Extra, Nov. 2). ...